論醫療商品之安全性欠缺──以美國法為借鏡

現代生活與醫療商品具有密切關係，醫療行為更難脫醫療商品之使用，於此同時，其亦可能肇致商品事故之發生，被害人所受之損害，能否予以充分填補，即成為民事責任法之重要議題。醫療商品製造商，不僅專精於商品之研發、製造，並藉此獲取商業利潤，更於醫療消費市場中，扮演著關鍵角色，從而，於損害事故填補之相關討論，其亦不容缺席。我國民法第191-1條及消費者保護法第7條等規定，創設「商品責任」之獨立責任類型，並成為現代商品事故被害人於尋求訴訟救濟時，最主要之請求權基礎。有別於傳統過失責任原則，商品責任之判斷核心，乃聚焦於「商品之客觀狀態」，以「安全性欠缺」合理分配損害、劃定責任界線。為求充實「安全性欠缺」之概念內涵，參酌比較法經驗，應得自設計、製造以及指示或警告等不同面向，將其具體區分為三個欠缺類型，並以一般、通常、理性消費者之合理期待，作為判斷標準。各該欠缺類型，分別具有不同之規範意義，從而，即便我國法採取概括、統合之安全性欠缺概念，將其予以具體化、類型化仍有其必要性。而醫療商品，包括疫苗、藥品以及「植入人體」之醫療器材，具有與一般商品相異之特殊性質，連帶影響其於商品責任法上安全性欠缺之解釋適用。本文認為，於「製造上欠缺」方面，醫療商品與一般商品實無不同，從而無需於此為差別處理，倘若個別商品悖離其原先預定之設計規格，即欠缺可合理期待之安全性。然而，由於醫療商品所具有之特殊風險效益關係，以及高度行政監管架構，職司審判之法院於醫療商品之「設計」方面，事實上著力點甚為有限，從而毋寧應就其「設計上欠缺」之責任論斷，採取謹慎、限縮之態度，並同時強化商品之資訊提供義務，以確保病患自主決定權得以落實。最後就「指示或警告上欠缺」觀之，美國法院於處方醫療商品，普遍採取「專業中間人原則」，認為製造商原則上對於商品之最終消費者、使用者，並不負有直接性義務，其僅須將相關資訊充分提供予開立處方之醫師，即履行其於商品責任法所負之指示或警告義務。然而，本文認為，以此等原則作為製造商之責任屏障，不僅忽略了消費者對於商品資訊之實際需求，更無助於其自主決定權之實踐，很可能會形成對患者不利、對醫師不公，對製造商卻過於寬貸的法律適用結果。從而，美國法之「專業中間人原則」，不應亦不宜為我國法所肯認，以令醫療商品製造商，對於消費者，仍負有直接性資訊提供義務。至於何等資訊應傳達予消費者知悉，則取決於對其而言是否具有實質重要性為斷。

關鍵字

醫療商品；疫苗；藥品；醫療器材；嚴格責任；無過失責任；安全性欠缺；可合理期待之安全性；專業中間人原則

並列摘要

Medical products are highly associated with modern life, especially medical treatment, which is inevitable to get away from the use of medical products. However, consumers may also suffer injuries from accidents caused by defective products. In this connection, whether the damage can be fully compensated has become a crucial issue in civil liability law. The debate on healthcare in Taiwan has long been focused on the medical negligence of doctors while remaining silent on the responsibility of the manufacturers of defective medical products. Article 191-1 of the Civil Code and Article 7 of the Consumer Protection Act have established an independent type of strict liability in tort for defective products. Under the said strict liability, consumers injured by defective products are no longer required to prove that the manufacturer is at fault; instead, the analysis of product liability focuses on the “defect” of a product. From a comparative law perspective, the concept of “defect” can be enriched by dividing it into three types: design defect, manufacturing defect, and warning defect, to determine whether a particular product meets the reasonable expectation of typical consumers or users. However, in light of the unique nature of medical products (including vaccines, drugs, and implants) and the high-level government scrutiny involved, medical products should be treated differently from other types of products in product liability law. Given the courts’ limited scope of judgment in respect of the design defectiveness of medical products, it is necessary to adopt a discreet and restricted approach in design defect litigation. In addition to the foregoing, the obligation of manufacturers to provide information on the medical products, including disclosure of the dangers contained therein, should be extended to ensure patient autonomy. With regard to warning defects, American courts generally adopt the “learned intermediary doctrine” in prescription product litigation, namely, the manufacturer’s duty to inform consumers of the product’s information is fulfilled when the manufacturer provides adequate information to the prescribing physicians. Given that the implementation of patient autonomy should be achieved through the full understanding of product information, this Article proposes that the rationale of the learned intermediary doctrine may not be justified under Taiwanese law. That is, the manufacturer of prescription products should assume the obligation of providing adequate information of the product directly to the ultimate consumer.

並列關鍵字

Medical Product ； Vaccine ； Drug ； Implant ； Medical Device ； Defect ； Strict Liability ； No-fault Liability ； Reasonably Expected Safety ； The Learned Intermediary Doctrine